MAUDE Adverse Event Report: HEALTHTRONICS, INC. LITHOTRON LITHOTRIPTER; LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE,UROLOGICAL

Model Number LITHOTRON

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

Initial evaluation by a field service engineer found an energy storage problem which was repaired and the device returned to the customer.Maintenance review and final investigation review in progress.

Event Description

Shock wave generator stopped shocking during the procedure.Procedure cancelled.

Manufacturer Narrative

Maintenance review show no history related to this issue.

• Brand Name: LITHOTRON LITHOTRIPTER
• Type of Device: LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE,UROLOGICAL
• Manufacturer (Section D): HEALTHTRONICS, INC.; 9825 spectrum drive; building 3; austin TX 78717
• Manufacturer (Section G): HEALTHTRONICS, INC.; 9825 spectrum drive; building 3; austin TX 78717
• Manufacturer Contact: deborah wilcoxen ; 9825 spectrum drive; building 3; austin, TX 78717 ; 5124398334
• MDR Report Key: 5661274
• MDR Text Key: 45660388
• Report Number: 3008262715-2016-00017
• Device Sequence Number: 1
• Product Code: LNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: LITHOTRON
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR